Regulatory Affair Specialist - Medical Device
- Azienda:Page Personnel
- Data:07 Agosto 2020
- Sede di lavoro:Lazio (Roma)
- Settore:Chimica / Farmaceutica / Healthcare
- Contratto:Contratto a tempo indeterminato
The resource responsible for regulatory affairs, reports directly to the AD and coordinates the regulatory activity for the Italian territory. The figure works transversely and in collaboration with the various Company Departments with the following main responsibilities: It defines, together with the management, the strategies for the registration of new products in Italy and/or abroad; He is responsible for the creation of the new registration dossiers; Monitor the current legislation on medical devices; Establishes and maintains technical/regulatory relationships with the competent Authorities; Periodically reports the status of activities to Management and ensures that the Company operates in compliance with all regulations Prepare administrative documents and technical documentation for new and/or existing products;
The ideal candidate has a master's degree in Pharmaceutical Chemistry, Pharmacy or equivalent. An indispensable requirement is having at least 3 years of experience in the RA Department preferably in the Medical Device field, and a good knowledge of the legislation on the subject. The management of junior resources is a plus.